Greg Ball Email & Phone Number

Gaithersburg, Maryland, US

• Created a Safety Statistics group embedded in the Global Vaccine Safety organizationo Provided strategic input on safety related submissions to regulatory agencies and responses to requests from regulatory agencieso.
• Co-leading the PhUSE Safety Analytics working group (with Mary Nilsson)o Envisioned and created the Safety Graphics Consortium, a network of existing working groups/project teams focused on safety graphics for clinical.

Rahway, New Jersey, US

• Co-led a company initiative between Clinical Safety Statistics (CSS) and Clinical Safety and Risk Management (CSRM) to develop a Standard Operating Procedure (SOP) for routine periodic review and evaluation of.
• Co-led the Biostatistics and Research Decision Sciences (BARDS) Early/Late-Stage Statistics Technical Issues Committee (ELSTIC) Safety Analysis working group to create and align guidance for study-level and.
• Co-mentored (with CSRM) and managed a postdoc to develop innovative, interdisciplinary methodologies, procedures, and tools to support the clinical safety signaling process
• Main driver of a cross-disciplinary company-wide initiative to develop an innovative new safety assessment process to improve the overall quality of safety monitoring and reporting and to comply with requirements for.
• Created, developed, and implemented a procedure, with a collaborative process and a quantitative framework, for review of aggregate blinded clinical trial data to support safety signal detection and risk management.

North Chicago, Illinois, US

• Designed and developed a new Bayesian methodology for safety monitoring with blinded data and led the cross-disciplinary effort to evaluate it in an ongoing study (Ball, 2011; Wen, Ball & Day, 2015) o Consulted with.
• Led the scientific evaluation of aggregate safety data for global regulatory approval of a 3-drug combination of direct-acting antivirals for the treatment of HCV o Developed and executed a cumulative meta-analytic.
• Provided statistical leadership for clinical development strategy in Acute Kidney Injury (AKI), for the design, analysis and reporting of clinical trials and for interacting with regulatory authorities o Consulted with.

• Developed a Bayesian method for safety monitoring with blinded data (Ball, 2008 and 2011)
• Participated on a project team to acquire a partner for further development of a compound
• Collaborated on project teams to quickly respond to evolving project needs and to design and carry out useful and informative analyses o Managed programmers and statisticians to ensure proper analyses were carried out.
• Helped colleagues with non-standard statistical analyses o Simulation for the effect of stratified randomization on study power o Cox regression with a time dependent covariate o Adjusted correlation analyses

Durham, North Carolina, US

• Interacted with clients regarding statistical analysis issues, carried out exploratory analyses and prepared presentations
• Created statistical analysis plans and table shells and wrote the statistical methods section for study protocols
• Reviewed statistical output, research proposals, and manuscripts and helped colleagues with non-standard statistical requests

• Participated on study teams to design and carry out analyses of clinical trial data and provided statistical consulting o Managed the statistical activities of projects and guided the efforts of statistical programmers.
• Implemented a retention-of-effect analysis in a non-inferiority trial
• Served as project manager for 2 studies
• Designed and implemented a workbook for generating statistical bids
• Constructed a statistical analysis plan template
• Helped revise the standard operating procedure for statistical analysis plans

• Assisted in the development and implementation of a nursing research program
• Provided statistical support for performance improvement initiatives

Houston, TX, US

• Collaborated with physicians to conduct oncology research and publish scientific paperso Determined early stopping rules with continuous Bayesian monitoring designso Studied the functional form of continuous variables.

West Lafayette, IN, US

• Taught graduate level probability and statistics courses to MBA and education students
• Analyzed the effect of feed treatments and additives on pork belly firmness
• Studied the effect of a resource seminar on student success in 1st year biology
• Investigated the effect of obesity on the risk of bladder cancer in household dogs
• Co-president of the statistic’s graduate student organization

• Created math labs with graphing calculators to reinforce critical concepts
• Implemented school projects with an architect to apply knowledge to real-world problems
• Hosted a Japanese teacher and a Swiss student to promote cultural diversity

Washington, DC, US

• Developed leadership, management and communication skills
• Assistant department head of 90 men

Doctor Of Philosophy (Phd), Biostatistics

Master Of Science (Ms), Statistics

Master Of Arts (Ma), Mathematics Teacher Education

Bachelor Of Arts (Ba), Economics